Leaflet DROSPIRENONA/ETINILESTRADIOL VALE 3mg / 0.03mg tablets


Indicated for: contraception

Route of administration: oral

Substance: ethinylestradiol + drospirenone (estrogen + progestogen)

ATC: G03AA12 (Genito urinary system and sex hormones | Hormonal contraceptives for systemic use | Progestogens and estrogens, fixed combinations)

Precautions:
Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Ethinylestradiol and drospirenone are used together in combined oral contraceptives to prevent pregnancy. This combination contains a synthetic estrogen (ethinylestradiol) and a newer-generation progestin (drospirenone), which work synergistically to inhibit ovulation, alter cervical mucus, and affect the endometrium, thereby preventing the implantation of a fertilized egg.

Drospirenone is a progestin with antiandrogenic and antimineralocorticoid properties, meaning it can reduce the effects of androgens (such as acne and seborrhea) and prevent water retention, helping to reduce bloating and weight gain associated with other contraceptives. Ethinylestradiol stabilizes the menstrual cycle and contributes to contraceptive efficacy. Together, these substances provide a safe and effective contraceptive method with additional benefits for skin and hormonal balance.

While this combination is effective, its use may cause side effects. The most common include nausea, headaches, breast tenderness, mood changes, and intermenstrual bleeding. In rare cases, more serious reactions may occur, such as venous thromboembolism, high blood pressure, or liver disorders. Women who smoke, especially those over 35 years old, are at an increased risk of cardiovascular complications.

This combination should be used as directed by a doctor, and the patient should adhere to the prescribed schedule to ensure contraceptive efficacy. Regular medical check-ups are important to monitor for potential side effects and assess overall health. If severe side effects occur, such as chest pain, difficulty breathing, or severe leg pain, immediate medical attention is necessary.

General data about DROSPIRENONA/ETINILESTRADIOL VALE 3mg / 0.03mg

  • Substance: ethinylestradiol + drospirenone
  • Date of last drug list: 01-06-2019
  • Commercial code: W65602001
  • Concentration: 3mg / 0.03mg
  • Pharmaceutical form: tablets
  • Quantity: 21
  • Product type: generic
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Pharmaceutical forms available for ethinylestradiol + drospirenone

Concentrations available for ethinylestradiol + drospirenone

  • 0.02mg/3mg
  • 0.03mg/3mg
  • 3mg/0.03mg